Abstract
PurposeMixing with liquids or soft foods is a common procedure to improve acceptability of oral medicines in children but may affect drug stability and the in vivo performance of the administered drug product. The aim of the present study was to obtain an overview of the variability of critical attributes of commonly used vehicles and to identify which vehicle characteristics need to be considered when developing in vitro methods for evaluating product quality.MethodsOne product of each vehicle listed in the FDA draft guidance “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration” was analyzed with regard to composition, calorific content and physicochemical properties.ResultsThe studied vehicles show wide variability, both in composition and physicochemical properties. No correlation was observed between vehicle composition and physicochemical properties. Comparison of results of the present study with previously published data also provided variability in physicochemical properties within individual vehicle types.ConclusionsTo identify acceptable (qualified) vehicles for global drug product labeling, it is important that the vehicles selected for in vitro compatibility screening reflect the variability in composition and essential physicochemical properties of the vehicles recommended on the product label, rather than relying on results obtained with a single vehicle of each type. Future activities will focus on the development of standardized dosing vehicles that can represent key vehicle characteristics in all their variability to ensure reliable risk assessment.
Highlights
Despite the growing awareness of the need for age-appropriate formulations, the number of authorized pediatric medicines available is still far behind that of adult medicines
Grapefruit juice is not recommended as a vehicle at all and honey is not recommended for children under the age of 12, they were included in the study, since dosing vehicles are not just used in pediatric patients, and other patient populations who are unable to swallow solid oral dosage forms
Results of the investigation of the composition and physicochemical properties of one of each of the vehicles listed in the FDA draft guidance document “Use of Liquids and/or Soft Foods as Vehicles for Drug Administration”, indicate that pH is an important, but not the only parameter that should be considered when evaluating the compatibility of liquids and soft foods used as vehicles for drug administration to children
Summary
Despite the growing awareness of the need for age-appropriate formulations, the number of authorized pediatric medicines available is still far behind that of adult medicines. Since there is still a huge need for child-appropriate dosage forms, manipulation of dosage forms is a common practice prior to drug administration to children. Manipulation is defined as the process of physically altering dosage forms in order to provide the prescribed dose and to enhance patient acceptability [1, 2]. Recommendations regarding suitable vehicles, that become part of the summary of product characteristics (SmPC) and patient information leaflet (PIL) of an individual drug product, are usually made on a product-specific basis. While the suitability of the vehicles listed in SmPCs and PILs has been proven in compatibility studies as part of their authorization and coadministration with them can be considered safe,
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